A clinical study to evaluate immune response and safety of Hepatitis E Vaccine in healthy subjects

Phase 2

• Registration Number: CTRI/2023/02/049637
• Lead Sponsor: Zydus Lifesciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Healthy subjects of either gender between 16 to 65 years of age (both inclusive) at the time of enrollment

2. Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator

3. No previous history of vaccination with any licensed or investigational Hepatitis E Vaccine

4. Informed consent from the adult subjects or from the parents of adolescent subjects ( <18 years). Additionally, assent from adolescent subjects

5. Adult subjects or parents of adolescent subjects literate enough to fill the diary card

6. Adult subjects or adolescent subjects and parents likely to be available for follow-up for entire duration of the study

Exclusion Criteria

1. History of hypersensitivity reaction or serious adverse event to any component of the vaccine

2. History of laboratory confirmed or suspected hepatitis / jaundice in the past

3. Fever of any origin or infectious disorder of 3 days or more within past one month

4. History of vaccination against Hepatitis B within past 10 years

5. Subjects with febrile illness (body temperature =37.5°C) at the time of enrollment

6. History of any vaccination within past one month

7. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder

8. Any confirmed or suspected immunosuppressive or immunodeficiency disorder (based on medical history); or subjects who have used any immunosuppressive or immunostimulant therapy in past 1 month

9. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy

10. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study

11. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)

12. Subject participated in another clinical study in the past 3 months or subject intends to participate in another clinical study during the study period

13. Subject with history of alcohol or drug abuse in the past one year

14. Any other reason for which the investigator feels that subject should not participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with seroconversion for anti-HEV IgG antibodiesTimepoint: At Day 210 (End of the study)

Secondary Outcome Measures

Name	Time	Method
Geometric mean titre of anti-HEV IgG antibodiesTimepoint: At Day 0, Day 30, Day 60 and Day 210;Local and systemic adverse events reportedTimepoint: Throughout the study duration;Proportion of subjects with seroconversion for anti-HEV IgG antibodiesTimepoint: At Day 30 and Day 60;Serious adverse events reportedTimepoint: Throughout the study duration